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Nordic Luveris Study

This study has been completed.
Sponsor:
Collaborators:
Regionshospitalet Viborg, Skive
Karolinska University Hospital
Helse Fonna
Turku Hospital
Odense University Hospital
Herlev Hospital
Holbaek Sygehus
Hvidovre University Hospital
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00553293
First received: November 2, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose
To study whether addition of human LH hormone (Luveris) during the final days of stimulation with recombinant FSH (Gonal-f) for controlled ovarian stimulation will be of benefit for patients undergoing in vitro fertilisation.

Condition Intervention Phase
Infertility
In Vitro Fertilization
 Drug: recombinant luteinizing hormone (Luveris)
Drug: recombinant follicle stimulating hormone (Gonal-f)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recombinant LH Supplementation to Recombinant FSH During the Final Days of Controlled Ovarian Stimulation for IVF: a Multicentre, Prospective, Randomized, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Hormones Infertility
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Ongoing pregnancy rate per started stimulation cycle [ Time Frame: ultrasound showing ongoing pregnancy ]

Secondary Outcome Measures:
  • Ongoing pregnancy in subgroups of patients with lo0w serum LH levels [ Time Frame: ultrasound for ongoing pregnancy in subgroups ]
Enrollment: 526
Study Start Date: August 2003
Study Completion Date: November 2004
Arms Assigned Interventions
Active Comparator: A,1
rFSH + rLH arm
 Drug: recombinant luteinizing hormone (Luveris)
75 iu/day form cycle day 6
Other Name: Luveris
Placebo Comparator: A,2
rFSH alone
 Drug: recombinant follicle stimulating hormone (Gonal-f)
rFSH 150 iu/day
Other Name: Gonal-f

  Eligibility
Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age below 40
  • Infertility treatable by IVF or ICSI
  • Regular cycles

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553293

Locations
Denmark
Anders Nyboe Andersen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Regionshospitalet Viborg, Skive
Karolinska University Hospital
Helse Fonna
Turku Hospital
Odense University Hospital
Herlev Hospital
Holbaek Sygehus
Hvidovre University Hospital
Investigators
Principal Investigator: Anders N Andersen, professor Fertility Clinic Rigshospitalet
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00553293     History of Changes
Other Study ID Numbers: KF02-035/03 
Study First Received: November 2, 2007
Last Updated: November 2, 2007
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
infertility
in vitro fertilization
LH supplementation
Benefits

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
 Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016